Effect of rEPO in FGF23 in ESRD Patients

Completed

• Conditions: Chronic Kidney Diseases; Anemia
• Interventions: Drug: Recombinant EPO

• Registration Number: NCT03803514
• Lead Sponsor: University of Chile

Brief Summary

Objective: To evaluate the effects of recombinant Erythropoietin (rEPO) in plasma levels of Fibroblast Growth Factor 23 (FGF23) in End-Stage Renal Disease (ESRD) patients in hemodialysis.

Method: Prospective cohort of ESRD patients in HD, where patients with or without rEPO therapy were compared. Measurements of plasma FGF23 were performed at baseline and during the complete study. Demographic, clinical and laboratory data will be obtained.

Follow-up period: 12 weeks.

Detailed Description

Experimental data has shown that recombinant erythropoietin (rEPO) increases plasma levels of Fibroblast Growth Factor 23 (FGF23) in murines, both health and with acute or chronic renal disease. Also, observational studies indicate an association between EPO and FGF23 levels in patients. Until now, it has not been demonstrated whether the use of rEPO does increase plasma FGF23 in End-Stage Renal Disease (ESRD) patients in hemodialysis (a population with a high use of this therapy for the management of chronic anemia).

Our objective was to evaluate whether the administration of rEPO increases plasma FGF23 levels in ESRD patients in hemodialysis.

We performed a prospective cohort with ESRD patients without rEPO therapy. We performed 2 groups: patients with requirements of rEPO therapy due to anemia (Hb \< 10 g/dL) and patients without rEPO therapy (Hb \> 10 g/dL).

We measured plasma FGF23 (intact and C-terminal) at baseline and during 12 weeks.

Demographic, clinical and laboratory data was obtained. Patients treated with rEPO received beta-epoetin (Recormon, Roche), according to current recommendations.

Patients were follow-up during 3 months to evaluate the effects of rEPO. Our primary outcome was changes in plasma intact FGF23 at 12 weeks, between both groups.

Study Timeline

• Study Start: 2017-08-15
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-14
• Primary Completion: 2019-03-31
• Study Completion: 2019-10-20
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-25
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• End-Stage Renal Disease
• Requirements of Hemodialysis
• At least 6 months since initiation of hemodialysis

Exclusion Criteria

• Pregnancy
• Treatment with rhEPO or analogs during the previous 6 months or earlier

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated group (rEPO)	Recombinant EPO	Patients with ESRD in HD, and medical indication of recombinant EPO for management of anemia (Hb \< 10 g/dL). Ambulatory hemodialysis 3 times per week. Recombinant beta-epoetin (Recormon) will be used, according to current recommendations. Clinical and laboratory data will be obtained before and during the study. The primary outcome (changes of plasma intact FGF23) will be measured during the follow-up, up to 12 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in plasma intact FGF23 levels	12 weeks	Measurements of plasma intact FGF23 levels

Secondary Outcome Measures

Name	Time	Method
Changes in plasma C-terminal FGF23 levels	12 weeks	Measurements of plasma C-terminal FGF23 levels
Changes in hematocrit and hemoglobin	12 weeks	Measurements of hematocrit and hemoglobin in blood samples
Changes in parathormone levels	12 weeks	Measurements of parathormone levels in blood samples

Trial Locations

Locations (1)

Hospital Clinico Universidad de Chile; 🇨🇱 Santiago, Chile